Study Study Population Treatment/ intervention Results Validity

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Study
Rosenberg et al,
2013.
Study Population
Inclusion criteria:
Patients referred for
Holter monitoring for
the evaluation of
paroxysmal AF and to
document a response
to therapy and
potentially diagnose
other arrhythmias.
Treatment/
intervention
All patients were
®
given a Zio Patch
and instructed to
Study type:
wear the device and
Comparison of
press the trigger
diagnostic tests.
button when they felt
symptoms. They
Aim:
were instructed to
®
To compare Zio
wear the patch for as
Patch with a 24long as possible with
Patients
hour Holter
the goal of obtaining
characteristics:
monitor.
14 days of recording.
All patients had
The rhythm data
Endpoints:
paroxysmal AF, their were collected on the
mean age was 64.5
Correlation
device which was
years, 54.7% males, then sent back to the
between Holter
®
and 93.9% were
monitor and Zio
manufacturer to
Caucasians. 48% had analyze the data
Patch for
hypertension, 8%
identifying AF
using proprietary
diabetes, 5.3% CHF, algorithm.
events and
and 4% CAD. 50.7%
estimating AF
were receiving BAll patients were also
burden.
blockers, 21.3%
given a 24-hour
calcium channel
N of patients:
Holter monitor to
N=74 consecutive blockers, 32% were on wear simultaneously
®
antiarrhythmic
patients.
with the Zio Patch,
medication. 67.1%
with the same
had symptomatic AF, instructions to record
Blinding:
21.3% underwent
Yes, the
any symptoms during
previous
investigators
this period. Holter
®
cardioversion, and
reading the Zio
rhythm data were
Patch were blinded 10.3% prior pulmonary analyzed by an
vein isolation.
to the reports of
independent clinical
the 24-hour Holter
cardiologist.
monitor.
Gold standard:
Holter monitoring.
Results
•Significant arrhythmias were defined as atrial fibrillation or flutter (grouped as one category),
other supraventricular tachycardias for >4 beats, sustained ventricular tachycardia >4 beats,
junctional rhythm, sinus bradycardia (<50 beats/min), and complete or high grade heart block.
•Mean monitoring time for Holter monitor 22.5 +1.8 hours
®
•Mean monitoring time for Zio Patch 10.8 +2.8 days (range 4-14)
Validity
/Conclusion
Advantages/
limitations:
The pilot study had the
advantage of
®
comparing the Zio
Patch to 24-hour
®
•During the first 24 hours, when patients wore both the Zio Patch and Holter monitor
Holter monitor.
simultaneously, 25 AF episodes were recorded on both.
However, it was a
®
Holter monitor
Zio Patch
r*
p
small single center
Mean AF burden
study that included
AF detected in first 24 hours
58.4 + 42.7%
54.7 + 41.2% 0.96
<0.001
patients with
*Correlation
symptomatic AF which
Change in classification of AF based on Zio Patch findings
®
does not allow
Zio Patch
studying the device in
None
Paroxysmal Persistent
Total
patients with silent AF.
H
None
32
17
0
49
O
The device was
L
12*
Paroxysmal
0
12
0
compared to 24-hour
T
Holter monitor and not
E
9*
Persistent
0
4
5
to other longer-term
R
outpatient ambulatory
Total
32
33
5
70
cardiac rhythm
monitors.
®
*Clinical classification of AF pattern changed as a result of Zio Patch in 21 patients
The results of the
•In patients without AF on clinic ECG or 24-hour Holter, the median time to detection was
study show that the
3.7+3.0 days. 90% of first AF events were detected by day 7.
®
Zio Patch was able to
®
detect more AF
•AF was detected with Zio Patch in 18 more patients compared to Holter (p<0.0001)
®
episodes than Holter
•Estimated AF burden was available for all 43 patients with detected AF with Zio Patch:
monitor, and had a
28.4%
comparable ability to
•Estimated AF burden was available for 21/25 patients with detected AF on Holter 58.4%
®
quantify AF burden It
•In addition to AF episodes, the Zio Patch also identified ventricular and
was able to identify
supraventricular tachycardia in 18 and 25 patients respectively. AV block was
other arrhythmias due
recorded in one patient.
to the longer duration
®
Clinical utility: Management was changed in 21 patients as a result of the Zio Patch of recording. The
study: Antiarrhythmic medication was changed in 13 patients, anticoagulant therapy author recommended
that larger studies are
(initiated or stopped) in 4 patients. 2 patients received pacemakers,
recommendations for AV junction ablation was for one patient, pulmonary ablation in necessary to
determine the efficacy
one patient, and cardioversion in 2 patients.
®
of Zio Patch in overall
®
arrhythmia detection
Reasons for discontinuing use of Zio Patch:
and its cost effectives
Study completion
49 patients (66.2%)
compared to other
Device falling off
16 patients (21.6%) after a mean of 7.9 days
ambulatory monitors.
Patients decision
6 patients (8.1%)
Battery malfunction, unknown, or need for intervention: 1 patient for each